Clearance Summary
INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 received FDA 510(k) clearance under submission number K913973, sponsored by National Health-Care Equipment, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1991-11-29.
- Submission: K913973
- Applicant / Sponsor: National Health-Care Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 1991-11-29
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.